Before 1990, the medical devices sector was not governed directly by any European legislation in the European Union (E.U.). The lack of harmonization of E.U. member states’ rules resulted in two major problems: difficulties in regulating the behavior of the market and a hurdle to the free movement of principal goods within the E.U. (articles 34 to 36 of the Treaty on the Functioning of the European Union). Medical devices are subject to this free movement principle as they are considered “goods.” Therefore, in order to protect the public health and to improve the medical device market, a set of rules specifically for medical devices was created.
It is in this context that the first council directive intervened: Directive 90/385/EEC. Since then, about ten directives applicable to medical devices have completed the regulatory system in the E.U. Each type of medical device has a directive of reference: for example, in vitro medical devices are governed by Directive 98/79/EC.
In the E.U., the medical device approval process is faster and easier than in United-States. The fundamental difference is the use of CE marking, an official recognition stating the medical device is harmless and ready to enter the market. It is commonly called the “New Approach.”
However, in order to have such authorization and to protect public health, the manufacturer must comply with compulsory essential requirements of security and performance in the medical device directive. To respect these essential requirements permits a presumption of conformity which will be declared by the medical device manufacturer to the applicable competent authority (in France, the French Agency for the Safety of Health Products).
A discussion of the details of the E.U. process and special features of the French approval process can be helpful. In this post, we will address E.U. medical device classification and the technical file requirements.
Classification: First, determine the type of medical device. This step is very important because the rules differ. To classify a product, the manufacturer must study the annex IX classification criteria of Directive 93/42/EEC. The E.U. classification system is different from the U.S. classification system, often resulting in absurdities such as having a product classified as class III in the U.S., but classified as only a class IIa and class IIb in the E.U. As you can imagine, this creates difficulties for medical device manufacturers in managing day-to-day compliance efforts and also creates confusion regarding the true risk level of the product.
|Lower Risk||Class I are non-invasive devices and Class I with sterile or measuring function||Class I includes both sterile and measuring function|
|Class IIa and IIb||Class II|
|High Risk||Class III||Class III|
Annex IX presents the rules to classify the medical device in one of the four categories. Typical classification criteria are length of use, invasive or non-invasive devices, the possibility to reuse the device, and the device’s bodily destination. Rules 1 through 4 apply to non-invasive devices, rules 5 through 8 for invasive devices, rules 9 through 12 for active devices, and rules from 13 through 18 for special categories of devices.
Medical device companies considering a launch in the E.U. market may also want to consider a parallel U.S. medical device classification. Proactive work in preparing the regulatory strategy is useful in determining in which market to seek approval.
The technical file: This part of the process is crucial because it substantiates that all essential requirements have been fulfilled by the medical device manufacturer. Consequently, the technical file is relied upon for the premise that the product is safe and performs as intended.
Security (Safety): The aim is the protection of patients and public health. That is why the product must be safe for the patient, the users (doctors), and any third person (family). The security is established regarding existing techniques in the market. This notion is the reference for manufacturer—a sort of existing knowledge.
Performance: The medical device must perform as intended.
Side effects and adverse events: They should be very low. Attention should be given to the fact that the manufacturer must also know how to declare and report adverse events. Vigilant reporting must be documented in the technical file.
Maintenance (shelf-life, performance life): The medical device must keep all its characteristics as long as it is used (or intended to be used). The conditioning and the transportation of the device must be subject to strict rules, especially for high-risk devices like pacemakers.
Manufacturing process: There are essential requirements concerning the conception (similar to design controls in the U.S.) and the manufacturing process, including clinical trials and assessments, labeling, etc. It is important to include in the first clinical trial, when necessary, evidence of a real clinical benefit.
All these technical file requirements later become part of the quality management system of the medical device post-market. The reference often used by device companies is the ISO 13485:2003 standard. However, the harmonized standards of the directive are sufficient. Assert the presumption of conformity and the ISO standard is not required by the medical device directive.